Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K993878 |
Device Name |
JE 2000 |
Applicant |
JACK'S ELECTRODES |
2227 EAST CRESCENT DR. |
ALTADENA,
CA
91001
|
|
Applicant Contact |
ANTHONY R.H. FENDER |
Correspondent |
JACK'S ELECTRODES |
2227 EAST CRESCENT DR. |
ALTADENA,
CA
91001
|
|
Correspondent Contact |
ANTHONY R.H. FENDER |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 11/15/1999 |
Decision Date | 02/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|